Product Safety Recalls

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ALBUTEROL SULFATE Recall D-1023-2022

Description: Albuterol Sulfate Inhalation Aerosol HFA with Dose Indicator, 90 mcg, 200 metered inhalations, Rx only, Manufactured for: PAR Pharmaceutical, NDC 0254-1007-52

ALBUTEROL SULFATE Recall D-1023-2022 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-1023-2022
Event ID89646
BrandALBUTEROL SULFATE
Generic NameALBUTEROL SULFATE
ManufacturerALBUTEROL SULFATE
Original Package?1
Active SubstanceALBUTEROL SULFATE
Drug RouteRESPIRATORY (INHALATION)
DistributionUSA nationwide.
Quantity5 aerosols
Recall ReasoncGMP deviations: Temperature abuse
Drug ClassificationClass II
Drug Code Info20220615
Product NDC0254-1007
Recall Initiation Date20220413
Report Date20220615
Classification Date20220609
Address9954 Maryland DriveDeep Run Iii Ste. 4000
Richmond, VA 23233
United States
Recalling FirmMckesson Medical-Surgical Inc. Corporate Office
Initial Notification Letter
Unique Ingredient Identifier021SEF3731
Drug Application NumberNDA020503
Structured Product Labeling (SPL ID)bd0c8367-59b1-60be-e053-2995a90a6b85
Structured Product Labeling (SPL Set ID)498c7eff-645b-4a79-be12-afe9dbd5f3c4
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